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Home Biofeedback Therapy for Bowel and Urinary Incontinence (Bioanatoner Trial)
N/A
Recruiting
Led By Satish Rao, MD, PhD
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with constipation and dyssynergic defecation must meet Rome IV criteria for functional constipation with specific symptoms
Patients with constipation and dyssynergic defecation must demonstrate a dyssynergic pattern of defecation during repeated attempts, as well as specific criteria on anorectal manometry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks & 12 weeks
Awards & highlights
Bioanatoner Trial Summary
This trial tests a home biofeedback system to help people with constipation, urinary leakage, or stool leakage. It will compare it to standard care and look at its safety and cost-effectiveness.
Who is the study for?
This trial is for individuals with bowel or urinary incontinence, or bedwetting. Participants must have had symptoms for several months and meet specific diary criteria. Those with constipation need to fit the Rome IV criteria and show a certain pattern on tests. People can't join if they have related structural diseases, severe health conditions, are using opioids recently, or are pregnant/nursing.Check my eligibility
What is being tested?
The study is testing home biofeedback therapy using wireless devices and apps against office-based therapy to treat defecation issues and incontinence. It aims to see which method is more effective, safer, and cost-efficient by comparing patient outcomes from both treatments.See study design
What are the potential side effects?
While not explicitly stated here, biofeedback therapy generally has minimal side effects but may include discomfort during use of the equipment or minor psychological stress due to self-monitoring.
Bioanatoner Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I meet the specific criteria for functional constipation.
Select...
I have constipation due to muscle coordination issues, confirmed by a special test.
Bioanatoner Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks & 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks & 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of complete spontaneous bowel movements (CSBM) per week for patients with dyssynergic defecation
the number of Urinary Incontinence (UI) episodes for UI group
the number of fecal incontinence (FI) episodes for the FI group
Secondary outcome measures
Amplitudes (Millivolts of the nerve) for lumbo-rectal Motor Evoked Potential (MEP) for patients within all 3 groups
Amplitudes (Millivolts of the nerve) for sacro-rectal Motor Evoked Potential (MEP) for patients within all 3 groups
Anal Sphincter Function-Anal Resting Pressure for patients within all 3 groups
+29 moreBioanatoner Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Home Biofeedback Therapy (HBT)Experimental Treatment1 Intervention
HBT for patients with constipation and dyssynergic defecation:
HBT for patients with FI
HBT for patients with UI
All patients will be advised to practice HBT at least once or twice a day for six weeks.
Group II: Office Biofeedback Therapy (OBT)Active Control1 Intervention
OBT for patients with constipation and dyssynergic defecation.
OBT for patients with FI.
OBT for patients with UI.
All patients will receive office biofeedback, once weekly, over six weeks.
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Who is running the clinical trial?
Augusta UniversityLead Sponsor
211 Previous Clinical Trials
84,996 Total Patients Enrolled
Satish Rao, MD, PhDPrincipal InvestigatorAugusta University
4 Previous Clinical Trials
121 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have trouble controlling your bowel movements, you must have had frequent episodes for at least six months and report at least one episode per week on a poop diary.I have fecal incontinence but do not have severe diarrhea, depression, certain illnesses, rectal issues, or am not pregnant/nursing.If you have trouble controlling your bladder, you need to have had ongoing issues for at least three months and your daily records of accidents need to match certain guidelines.I do not have ongoing urine leakage, depression, certain illnesses, rectal issues, or am not pregnant/nursing.I have constipation due to muscle coordination issues, confirmed by a special test.I meet the specific criteria for functional constipation.I have constipation without any major health issues, recent opioid use, or pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Home Biofeedback Therapy (HBT)
- Group 2: Office Biofeedback Therapy (OBT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the main objectives of this experiment?
"The primary metric of efficacy over the course of this 12-week trial will be evaluating the number of fecal incontinence (FI) episodes in patients with FI. Secondary outcomes include measuring stool consistence using Bristol Stool Scale, quantifying spontaneous bowel movements for those with dyssynergic defecation, and rating straining effort on a 1-3 scale for participants with dyssynergic defecation; higher scores indicating more severe strain."
Answered by AI
Are individuals able to participate in this clinical examination at the moment?
"This research is still open for recruitment, as indicated on clinicaltrials.gov. The first posting was made on March 27th 2023 and the information was last edited a mere 17 days later on April 14th."
Answered by AI
Could you provide an estimate of how many individuals are participating in this trial?
"Affirmative. The information available on clinicaltrials.gov explicitly states that this medical trial is presently recruiting individuals to join the study; initially posted in March of 2023 and last updated few weeks later, they are currently searching for 72 people from one site."
Answered by AI
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